Medical Breast, Head & Neck, and Investigational Drug Development

Introduction

The Division of Oncology and Hematology has been managing variety of malignancies including breast cancer, malignant lymphoma, head and neck cancers, lung cancer and primary unknown carcinoma. Our clinical and research activities are mainly focused on the following five fields: 1) Development of newly synthesized anticancer agent through phase I trails, 2) Disease oriented clinical trials especially for breast cancer, head & neck cancers, malignant lymphomas and hematological malignancies, 3) High dose chemotherapy with autologous bone marrow transplantation (BMT) and/or peripheral blood stem cell support in experimental setting, 4) Standard chemotherapy treatment as clinical practice, 5) Palliative care for terminal stage patients. However, number of phase I trials have been decreasing in recent years, because most of pharmaceutical companies in Japan intend to start early phase clinical trials outside Japan.

Routine Activities

We managed many kinds of malignant disease in the past year including breast cancer, non-Hodgkin's lymphoma, Hodgkin disease, acute leukemia, lung cancer, colorectal cancer, pharyngeal and laryngeal cancers, pancreatic cancers, soft tissue sarcomas, uterine cancer, ovarian cancer as well as primary unknown adenocarcinoma. For the diseases with established standard chemotherapy and without phase III clinical trial project, routine chemotherapy was administered as clinical practice. Experimental therapeutics was conducted for patients without standard treatment or who failed standard chemo-therapy.

Research Activities

(1) Phase I of weekly dosing of docetaxel

This phase I trial is the first official weekly docetaxel phase I trial which is sponsored by RPR in the world. Both National Cancer Center Hospital East and National Shikoku Cancer Center collaborated to the project. At present time, we defined 35 mg/sqm/week for 3 consecutive dosing as MTD.

(2) Phase I of UCN-01

Clinical development of new proteinkinase C inhibitor UCN-01 was conducted both by National Cancer Center of Japan and by National Cancer Institute in the U.S. Although administration schedule of our phase I is 3 hours infusion, which is different from U.S. study of 71 hours infusion, exchange of clinical information for each other is quite informative. We are at the final stage of this phase I trial.

Clinical Trials

The following clinical trials were conducted in 1999:

Phase I Trials

-UCN-01

-Weekly docetaxel

-CGP42446

Phase I/II Trial

-Nedaplatin + 5FU (head and neck cancer)

-Oxicontin PK/PD trial

Phase II Trials

-SMS201-995

-Docetaxel+ADR (breast cancer)

-CHOP+Rituximab or Rituximab (lymphoma)

-Cisplatin+Docetaxel (head and neck cancer)

-Docetaxel/or Paclitaxel and Herceptin (breast cancer)

-Capecitabine (breast cancer)

Phase III Trials

-JCOG (Japan Clinical Oncology Group) breast cancer trials

-JALSG (Japan Acute Leukemia Study Group) for leukemia

-JCOG (Japan Clinical Oncology Group) lymphoma study

-CGS20267

Protocols and Number of Patients Attended
Protocol	No of Patients
UCN-01	3
Weekly DTL	7
Oxicontin	4
SMS201-995	2
CGS20267	4
DTL+CDDP	5
254S+5FU	4
Docetaxel+ADR	3
Docetaxel/Hct	4
Capecitabine	10

(Y. SASAKI)

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